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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02592720
Other study ID # Cocktail II-FFR ACS
Secondary ID
Status Recruiting
Phase Phase 4
First received October 27, 2015
Last updated October 29, 2015
Start date October 2015
Est. completion date October 2017

Study information

Verified date October 2015
Source Xijing Hospital
Contact Wanrong Man, MD
Phone 86 29 84775183
Email manwanrong@gmail.com
Is FDA regulated No
Health authority China: National Natural Science Foundation
Study type Interventional

Clinical Trial Summary

This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS).


Description:

This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). Patients with ACS will be randomized into the cocktail plus FFR guided group or the QCA guided group. The primary outcome of the cocktail II study is the composite of death, myocardial infarction, class IV heart failure and target vessel revascularization within 1 year. The secondary outcome of the cocktail II study include left ventricular function, quality of life, stroke or life-threatening bleeding within 1 year.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date October 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- patients with a clinical diagnosis of recent ACS within 5 days

Exclusion Criteria:

- haemodynamic instability

- intolerance to anti-platelet drugs

- ineligible for coronary revascularization

- a treatment plan for non-coronary heart surgery (e.g. valve surgery)

- a history of prior PCI or CABG

- angiographic evidence of severe (e.g. diffuse calcification) or mild (<30% severity) coronary disease

- a life expectancy less than 1 year

- adenosine allergy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
cocktail
Intracoronary cocktail injection before fractional flow reserve (FFR) measurement. Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).
Device:
FFR
Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).
QCA guided group
Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS).

Locations

Country Name City State
China Xijing hospital Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major adverse cardiac events number of participants with death, myocardial infarction or class IV heart failure and target vessel revascularization revascularization 1 year Yes
Secondary left ventricular function left ventricular ejection fraction evaluated by ultrasound and MRI 1 year No
Secondary Seattle Angina Questionnaire scores Seattle Angina Questionnaire scores 1 year No
Secondary Canadian Cardiovascular Society (CCS) Functional Angina classification Canadian Cardiovascular Society (CCS) Functional Angina classification 1 year No
Secondary 6-minute walk distance (6MWD) 6-minute walk distance (6MWD) 1 year No
Secondary stroke number of participants with stroke 1 year Yes
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